ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01647750

Protocol/serial number

12397

Study information

Scientific title

Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED)

Acronym

SORTED

Study hypothesis

All patients with hypothyroidism are currently treated the same way, regardless of age. We want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why we think this could be beneficial, but this is not yet proven:1. Some older people with hypothyroidism may have few symptoms.2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patients blood to decide the dose of Thyroxine received. The standard normal TSH range used to determine the dose of levothyroxine is from younger people. We wonder whether this is appropriate to all age ranges particularly as we know that older people may normally have higher TSH values.3. If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.

The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before we can do this, we need to run a smaller clinical trial called a pilot study (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above.

Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks.

We also propose a qualitative study (SORTED 2) to specifically understand patients willingness to take part in a RCT and participants experience of the intervention.

Finally, we propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.

Intervention

Patients will be randomised to receive either standard or lower dose dose Levothyroxine

Intervention type

Drug

Phase

Not Applicable

Drug names

Levothyroxine

Primary outcome measure

Patients willingess to participate and acceptability of study design; Timepoint(s): For the duration of the SORTED 1 study

Secondary outcome measures

1. Assessment of change in specific cardiovascular risk factors2. Assessment of dose titration strategy3. Assessment of length of time to achieve desired TSH level4. Assessment of mobility and risk of falls in this population group5. Assessment of participant recruitment rate; Timepoint(s): Over the duration of the SORTED 1 study, until last patient is randomised; Assessment of 6. Use of quality of life questionnaires

Assessed over the duration of the SORTED 1 study

Overall trial start date

01/07/2012

Overall trial end date

30/06/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males and females aged 80 years or older2. Diagnosed with hypothyroidism and treated with LT4 for at least 6 months3. Living independently in the community4. All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study5. Participant has provided written informed consent for participation in the study, prior to any study-specific procedures

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 68; UK Sample Size: 68

Participant exclusion criteria

1. Established dementia and therefore deemed incapable of providing informed consent.2. Other medical conditions which, in the opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)3. Nursing Homes or Residential Care Home residents4. Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH6. Individuals on 25 mcg daily of LT4: dose reduction will mean that they stop thyroid replacement treatment7. Non English speaking individuals8. Participation in any other investigational trials within the last 3 months9. Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil)10. Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)

Recruitment start date

01/07/2012

Recruitment end date

30/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom